Vitiligo and Psychological Distress: Pilot Study for the Experimentation of a Psychodramatic Psychotherapy Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Improvement of the levels of psychological distress of patients with vitiligo, in terms of anxiety symptoms
研究概览
简要总结
The goal of this pilot clinical trial is to assess the effectiveness of psychodramatic psychotherapy in reducing the psychological distress and/or the skin condition in patients with vitiligo.
The main questions it aims to answer are:
- Is there any improvement in terms of psychological distress in patients with vitiligo participating in a psychodramatic psychotherapy, compared to a control group?
- Is there any improvement in terms of skin condition in patients with vitiligo participating in a psychodramatic psychotherapy, compared to a control group? Participants in the experimental group will receive the dermatological drug treatment usually recommended for vitiligo, and in addition they will participate in a 6 months psychodramatic psychotherapy.
Researchers will compare the results of the experimental group with the results of a control group including vitiligo patients who will receive the dermatological pharmacological treatment usually recommended for vitiligo and participate in a 6 months program of self-help activities.
详细描述
The primary aim of this pilot study is to assess any possible improvement in terms of psychological distress in patients with vitiligo participating in a psychodramatic psychotherapy (PSD), in addition to the usual pharmacological treatment with hydrocortisone and heliotherapy.
The secondary aim is to assess any improvement in terms of vitiligo skin condition and/or other systemic autoimmune diseases symptoms.
The study will involve 24 patients with vitiligo aged between 18 and 55 years, attending the dermatology services of the Azienda Provinciale per i Servizi Sanitari (APSS) of Trento.
Patients will be randomly assigned to one of the two groups:
- 12 patients will receive the dermatological pharmacological treatment usually recommended for vitiligo, and in addition they will participate in a psychodramatic group psychotherapy for 6 months (PSD experimental group);
- 12 patients will receive the dermatological pharmacological treatment usually recommended for vitiligo, and in addition they will receive self-help activities for 6 months (non-PSD control group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Segmental vitiligo with unilateral localization.
- •Non-segmental vitiligo (acrofacial; mucosal with more than one side affected; generalized universal; mixed associated with segmental vitiligo).
- •Vitiligo-associated autoimmune comorbidity referred to in points 1-2: Thyroiditis.
- •Symptoms of depression and/or anxiety and/or low self-esteem associated with Vitiligo mentioned in points 1-2.
排除标准
- •Cognitive impairment/dementia (clinically diagnosed).
- •Individual and/or group psychotherapy in progress.
- •Have previously received other psychotherapy.
- •Use of psychiatric drugs in the last 3 months.
结局指标
主要结局
Improvement of the levels of psychological distress of patients with vitiligo, in terms of anxiety symptoms
时间窗: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
The Beck Anxiety Inventory (B.A.I.), a self-report measure of anxiety, will be administered to all patients. The BAI items are scored on a scale between 0 and 3 and have a maximum score of 63, with higher scores suggestive of higher levels of anxiety.
Improvement of the levels of psychological distress of patients with vitiligo, in terms of spontaneity
时间窗: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
The Revised Spontaneity Assessment Inventory (SAI-R) will be administered to all patients. The SAI-R is a scale for the assessment of spontaneity, evaluating feelings and thoughts that people experience in different daily situations. It includes 18 items, scored on a 5-point Likert scale. Higher total scores indicate higher levels of spontaneity (score range: 18-90)
Improvement of the levels of psychological distress of patients with vitiligo, in terms of psychological, functional or physical state.
时间窗: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
The Short-Form Health Survey (SF-36): a health status profile originally designed to measure health status and outcomes, will be administered to all patients. This instrument addresses health concepts from the patient's perspective and its 36 questions are meant to reflect 8 domains of health, evaluating any changes in the psychological, functional or physical state of patients. SF-36 scores range from 0 (worst) to 100 (best).
Improvement of the levels of psychological distress of patients with vitiligo
时间窗: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
The General Health Questionnaire (GHQ-12), a self-administered questionnaire covering several domains associated with a person's psychological well-being, will be administered to all patients. Scoring is along a 4-point scale (total score ranging from 0 to 36) with higher scores suggestive of more distress.
Improvement of the levels of psychological distress of patients with vitiligo, in terms of depressive symptoms
时间窗: Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention
The Beck Depression Inventory (B.D.I.), a 21-question multiple-choice self-report inventory and one of the most widely used instruments for measuring the severity of depression, will be administered to all patients. A value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. Higher total scores indicate more severe depressive symptoms.
次要结局
- Improvement of vitiligo and/or other systemic autoimmune diseases symptoms, in terms of dermatological lesions related to vitiligo and any re-pigmentation(Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention)
- Improvement of vitiligo and/or other systemic autoimmune diseases symptoms, in terms of personal perception of the patient(Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention)
- Multidimensional improvement of vitiligo(Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention)
- Improvement of vitiligo and/or other systemic autoimmune diseases symptoms, in terms of quality of life associated with the skin condition(Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention)
- Improvement of other autoimmune diseases, in terms of levels of S-Free T4-Thyroxine(Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention)
- Improvement of other autoimmune diseases, in terms of levels of levels of Thyroid Stimulating Hormone(Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention)
- Improvement of other autoimmune diseases, in terms of levels of Anti Thyroglobulin(Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention)
- Improvement of other autoimmune diseases, in terms of levels of Anti Thyroperoxidase(Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention)
- Improvement of other autoimmune diseases, in terms of levels of Antinuclear Antibodies(Time 0: Before the beginning of the intervention; Time 1: after 6 months, at the end of the intervention)
研究者
Gabriella Pravata
Medical Doctor, Dermatologist
Azienda Sanitaria Universitaria Integrata del Trentino